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2 for Diffuse Large B-Cell Lymphoma (realMIND Trial)

N/A
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

The realMIND study is a multicenter, observational study intended to further characterize the safety and effectiveness data of US patients (with a focus on racial and ethnic minority patients) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), treated with tafasitamab in combination with lenalidomide.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Patterns - Effectiveness (a)
Treatment Patterns - Effectiveness (b)
Treatment Patterns - Effectiveness (c)
+4 more
Secondary outcome measures
Physician-reported clinical outcome (a)
Physician-reported clinical outcome (b)
Physician-reported clinical outcome (c)
+3 more

Side effects data

From 2023 Phase 2 trial • 81 Patients • NCT02399085
64%
Any TEAE
49%
Neutropenia
37%
Diarrhoea
37%
Anaemia
30%
Cough
28%
Thrombocytopenia
26%
Asthenia
25%
Oedema peripheral
22%
Pyrexia
22%
Decreased appetite
20%
Back pain
19%
Hypokalaemia
19%
Constipation
16%
Fatigue
15%
Vomiting
15%
Bronchitis
15%
Muscle spasms
15%
Nausea
12%
Leukopenia
12%
Urinary tract infection
12%
Dyspnoea
11%
Respiratory tract infection
11%
C-reactive protein increased
10%
Abdominal pain
10%
Nasopharyngitis
10%
Upper respiratory tract infection
10%
Pruritus
10%
Rash
10%
Pain in extremity
10%
Hypomagnesaemia
9%
Pneumonia
9%
Rhinitis
9%
Headache
9%
Paraesthesia
9%
Blood creatinine increased
9%
Hypertension
7%
Sinusitis
7%
Abdominal pain upper
7%
Mucosal inflammation
7%
Gastroenteritis
7%
Gamma-glutamyltransferase increased
7%
Anxiety
7%
Oropharyngeal pain
7%
Arthralgia
7%
Hypotension
6%
Febrile neutropenia
6%
Rash maculo-papular
6%
Sciatica
6%
Dysuria
6%
Blood alkaline phosphatase increased
6%
Hyperglycaemia
6%
Productive cough
6%
Lymphopenia
6%
Hypocalcaemia
6%
Hypogammaglobulinaemia
6%
Infusion related reaction
4%
COVID-19
4%
Pulmonary embolism
2%
Basal cell carcinoma
2%
Lower respiratory tract infection
2%
Squamous cell carcinoma
2%
Atrial fibrillation
2%
Cardiac failure congestive
1%
Bronchopulmonary aspergillosis
1%
Cerebrovascular accident
1%
Cervicobrachial syndrome
1%
Enterobacter bacteraemia
1%
Escherichia bacteraemia
1%
Febrile infection
1%
Influenza
1%
Klebsiella sepsis
1%
Transient global amnesia
1%
Sudden death
1%
Myelodysplastic syndrome
1%
Cholecystitis
1%
Haematoma
1%
Intervertebral discitis
1%
COVID-19 pneumonia
1%
Gastroenteritis rotavirus
1%
Bowen's disease
1%
Breast cancer
1%
Lung adenocarcinoma
1%
Prostate cancer
1%
Transient ischaemic attack
1%
Cardio-respiratory arrest
1%
Myeloproliferative neoplasm
1%
Cytomegalovirus infection
1%
Neutropenic sepsis
1%
Parainfluenzae virus infection
1%
Progressive multifocal leukoencephalopathy
1%
Respiratory syncytial virus infection
1%
Sepsis
1%
Soft tissue infection
1%
Streptococcal sepsis
1%
Urinary tract infection enterococcal
1%
Varicella zoster virus infection
1%
Lower limb fracture
1%
Wound complication
1%
Tumour flare
1%
Biliary colic
1%
Muscular weakness
1%
Agranulocytosis
1%
Cardiac failure
1%
Myocardial ischaemia
1%
Cognitive disorder
1%
Facial paralysis
1%
Chronic obstructive pulmonary disease
1%
Respiratory failure
1%
Arthritis
1%
Osteonecrosis
1%
Pathological fracture
1%
Femur fracture
1%
Renal failure
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (MOR00208, Lenalidomide)

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Group 2: Non Hispanic White (NHM) patients (at least 50 patients)
Group II: 1Experimental Treatment1 Intervention
Group 1: Racial and ethnic minority patients (at least 50 patients)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tafasitamab
2016
Completed Phase 3
~630

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
382 Previous Clinical Trials
56,952 Total Patients Enrolled
MorphoSys AGLead Sponsor
26 Previous Clinical Trials
6,496 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
112 Previous Clinical Trials
173,533 Total Patients Enrolled
~27 spots leftby Oct 2025
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